A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 13,885
- 试验地点
- 1
- 主要终点
- Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke
研究概览
简要总结
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.
详细描述
A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients 50 years old or older Symptomatic peripheral artery disease
排除标准
- •Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation
- •Patients with known bleeding disorders
- •Patients with a history of intracranial bleed
- •Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
研究组 & 干预措施
Ticagrelor
Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
干预措施: Ticagrelor (Drug)
Clopidogrel
Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke
时间窗: From randomization to PACD, an average of 2.5 years
Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)
次要结局
- Composite of CV Death, MI, Ischemic Stroke, and ALI(From randomization to PACD, an average of 2.5 years)
- CV Death(From randomization to PACD, an average of 2.5 years)
- MI(From randomization to PACD, an average of 2.5 years)
- All-cause Mortality(From randomization to PACD, an average of 2.5 years)
- Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)(From randomization to PACD, an average of 2.5 years)
- ALI(From randomization to PACD, an average of 2.5 years)
- Lower Extremity Revascularization(From randomization to PACD, an average of 2.5 years)
- Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])(From randomization to PACD, an average of 2.5 years)